FDA applicant
Healthpak, Inc.
FDA records 4 decisions for Healthpak, Inc. (Chicago, IL) from 1992 to 1993: 4 510(k) clearances. Most are in product codes KLC (Chair, Dental, With Operative Unit) and EAP (Unit, X-Ray, Intraoral). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Healthpak, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Healthpak, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Healthpak, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report